MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED STEALTH; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	RAD-SC30-150
Medical Device Problem Codes	Fluid/Blood Leak (1250); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported during the procedure, the stealth 360 peripheral orbital atherectomy device (oad) was leaking from the base and the viperwire guide wire was unable to be advanced through the oad.A new oad was used to complete the procedure.
Additional Manufacturer Narrative
A visual inspection, functional testing and dimensional analysis were performed on the returned device.The reported complaints of fluid leaking at the base of the device, and difficulty inserting the guide wire are confirmed.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported difficulty inserting the guide wire appears to be related to user error.Analysis identified a driveshaft kink that prevented a wire from passing through.The damage is likely due to handling during removal from the device packaging or during device set up.The stealth periph 1.5mm rad 200cm oad us instruction for use (ifu), in the warnings sections, states: ¿handle the oad and guide wire carefully.A tight loop, kink, or bend in the guide wire may cause damage and system malfunction during use.¿ during analysis, the fluid observed leaking out the base of the handle assembly did not appear to be abnormal.During use of the device, saline may accumulate in the handle and leak out around the green foot and does not indicate failure.Based on the results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: codes 4755, 4118, 3233, and 11 no longer apply.
Event or Problem Description
It was reported during the procedure, the stealth 360 peripheral orbital atherectomy device (oad) was leaking from the base and the viperwire guide wire was unable to be advanced through the oad.A new oad was used to complete the procedure.

• Brand Name: STEALTH
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INCORPORATED, #3004742232; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: alyssa mickelson ; 1225 old highway 8 nw; st. paul, MN 55112 ; 6517562718
• MDR Report Key: 21200613
• Report Number: 3004742232-2025-00019
• Device Sequence Number: 18276388
• Product Code: MCW
• UDI-Device Identifier: 10850000491318
• UDI-Public: (01)10850000491318(17)260430(10)537311-1
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K220568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: RAD-SC30-150
• Device Catalogue Number: RAD-SC30-150
• Device Lot Number: 537311-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2025
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 57 KG